MAUDE Adverse Event Report: NEUROPACE, INC. NEUROPACE RNS SYSTEM

Model Number	DL-330-10-K
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Numbness (2415); Hyperesthesia (4420)
Date of Event	11/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The explanted product was not returned to neuropace for analysis.The rns neurostimulator and leads remain implanted and programmed for use.
Event or Problem Description
Following an initial rns system implant on (b)(6) 2025, the patient reported hyperesthesia on her right face and right arm.She also reported tingling and some numbness.The rns neurostimulator and leads were placed on the patient's left side (opposite from affected side).The rns system was programmed for detection but not stimulation.On (b)(6) 2025 the patient reported to the emergency department with continued symptoms.A ct scan was performed at that time.Based on the ct scan the doctor indicated the patient's left hippocampal depth lead may not have been optimally placed.On (b)(6) 2025 the patient's left hippocampal depth lead was replaced.The physician has reported the patient is healing well, she is still reporting some right sided symptoms, which are being monitored by the physician.

• Brand Name: NEUROPACE RNS SYSTEM
• Common Device Name: NEUROPACE RNS SYSTEM
• Manufacturer (Section D): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer (Section G): NEUROPACE, INC.; 455 n. bernardo ave.; mountain view CA 94043
• Manufacturer Contact: ramona gonis ; 455 n. bernardo ave.; mountain view, CA 94043 ; 5108822607
• MDR Report Key: 23857725
• Report Number: 3004426659-2025-00091
• Device Sequence Number: 10375018
• Product Code: PFN
• UDI-Device Identifier: 00855547005335
• UDI-Public: 010085554700533517280123
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DL-330-10-K
• Device Catalogue Number: 1007929
• Device Lot Number: 35095-1-1-1
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 44 YR
• Patient Sex: Female